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Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00953862
First received: August 4, 2009
Last updated: March 7, 2016
Last verified: March 2016
Results First Received: April 11, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Intervention: Drug: Atomoxetine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participants were adult Odyssey House residents who met DSM-IV criteria for ADHD based on the Adult ADHD Clinician Diagnostic Scale v1.2 (ACDS v1.2) and drug and/or alcohol dependence based on Structured Clinical Interview for DSM Disorders - Patient Edition (SCID-I/P). Study was conducted from July 2005 to February 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded if they had a diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder, as assessed by clinical history and the SCID-I/P; seizure history (other than febrile seizures); current chronic or acute illness or medical condition, glaucoma, organic brain disease, traumatic brain injury, pregnancy, or lactation.

Reporting Groups
  Description
Atomoxetine Arm

Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.

Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.


Participant Flow:   Overall Study
    Atomoxetine Arm
STARTED   18 
COMPLETED   12 
NOT COMPLETED   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This number is the total number who were found eligible for the treatment.

Reporting Groups
  Description
Treatment

Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.

Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.


Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.8  (10) 
Gender 
[Units: Participants]
 
Female   3 
Male   15 
Race/Ethnicity, Customized 
[Units: Participants]
 
African-American   12 
Caucasian   3 
Hispanic   3 
Substance Used 
[Units: Participants]
 
Cocaine   6 
Cannabis   5 
Alcohol   3 
Opioid   3 
Other/Unable to report   1 
Length of Abstinence from all Substances 
[Units: Weeks]
Mean (Standard Deviation)
 14.1  (18.5) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Adult ADHD Investigator Symptom Rating Scale Score   [ Time Frame: Baseline and week 10 of treatment ]

2.  Secondary:   Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score   [ Time Frame: Baseline and week 10 of treatment ]

3.  Secondary:   Change in Clinical Global Impression-- Severity of Illness Score   [ Time Frame: Baseline and week 10 of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Lenard Adler
Organization: NYU School of Medicine
phone: (212) 263-3580
e-mail: lenard.adler@nyumc.org



Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00953862     History of Changes
Other Study ID Numbers: IRB#12233
BAZ-US-X031
Study First Received: August 4, 2009
Results First Received: April 11, 2013
Last Updated: March 7, 2016
Health Authority: United States: Institutional Review Board